Guidelines and Frameworks in Real-World Evidence (RWE)–Don’t Drown in the Alphabet Soup!

When you design a traditional clinical trial, the path is well-worn. CONSORT tells you what to report, ICH-E9 tells you what to plan, and decades of regulatory precedent tell you what questions to expect. The story arc is familiar: randomize, blind, follow protocol, analyze as planned, report transparently. There are many controversies and disagreements in traditional trials, but they exist within an established framework.